Powerful clinical efficacy across patient groups

 

In 1st line with letrozole
In a post-hoc pooled PFS analysis of PALOMA-1 and PALOMA-2, IBRANCE® + letrozole demonstrated PFS improvements vs placebo + letrozole in elderly patients*†2

  • 44% and 40.8% of patients treated with IBRANCE® + letrozole were aged ≥65 years in PALOMA-1† and PALOMA-2, respectively3,4
clinical-efficacy-across-patient-groups

 

 

Small patient numbers can be a limitation of subgroup analyses. These analyses are not intended to demonstrate efficacy in particular subgroups. No adjustments were made for multiple comparisons in the subgroup analyses.

Adapted from Rugo H, et al. 2018.2
Data cut-off dates: November 29, 2013 for PALOMA-1 and February 26, 2016 for PALOMA-2.
*Evaluated according to RECIST Version 1.1.3,4  PALOMA-1 was an open-label, randomised, Phase II study to assess the safety and efficacy of IBRANCE in combination with letrozole as 1st line treatment of patients with ER+/HER2- ABC. The study design of PALOMA-1 is similar to that of PALOMA-2 (PALOMA-2 was double-blind).3

In 1st or later line with fulvestrant
In a post-hoc subgroup analysis of PALOMA-3, IBRANCE® + fulvestrant in 1st line or later demonstrated mPFS improvements vs placebo + fulvestrant in elderly patients*2

  • In PALOMA-3, 24.8% of patients treated with IBRANCE® + fulvestrant were aged ≥65 years2clinical-efficacy-across-patient-groups
 
 

These analyses are considered exploratory. No adjustments were made for multiple comparisons in the subgroup analyses. Small patient numbers can be a limitation of subgroup analyses. These analyses are not intended to demonstrate efficacy in particular subgroups.

Adapted from Rugo H, et al. 2018.2
Data cut-off date: October 23, 2015.
*Evaluated according to RECIST Version 1.1.5

ABC = advanced breast cancer; CI = confidence interval; ER+/HER2- = estrogen receptor-positive, human epidermal growth factor receptor 2-negative; FUL = fulvestrant; HR = hazard ratio; LET = letrozole; mPFS = median progression-free survival; = number of patients; NE = not estimable; PFS = progression-free survival; PLA = placebo; RECIST = Response Evaluation Criteria in Solid Tumors.

References
  1. IBRANCE® Summary of Product Characteristics.
  2. Rugo H, et al. Eur J Cancer. 2018;101:123-133.
  3. Finn RS, et al. Lancet Oncol. 2015;16(1):25-35.
  4. Finn RS, et al. N Engl J Med. 2016;375(20):1925-1936.
  5. Cristofanilli M, et al. Lancet Oncol. 2016;17(4):425-439.

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